K232416
- 510(k) number
- K232416
- Device name
- AUTION EYE AI-4510 Urine Particle Analysis System
- Applicant
- Arkray, Inc. JP
- Product code
- LKM — Counter, Urine Particle
- Decision date
- 2024-05-03
- Date received
- 2023-08-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Hematology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K232416.pdf
Official FDA record: K232416
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.